Nevertheless, GSK said last week that it had received a so-called complete response letter from the agency, indicating that approval was not immediately forthcoming. The company said it was "triggered due to an administrative matter that has recently been rectified."

GSK did not say exactly what the problem was. The firm indicated that it was working with agency officials "to complete the review in a timely manner."

Recent strains of the H5N1 virus circulating in parts of Asia and the Middle East have not been infectious in human-to-human transmission, but in patients who have contracted the virus from poultry, it has been highly lethal. Public health authorities and virologists have worried that relatively small changes in the viral genome could turn it into a major killer.

No Help in Quitting for Most Smokers with Lung Cancer

Only about 40% of physicians who treat lung cancer patients said they routinely provide help in smoking cessation to their patients, according to a survey of more than 1,500 members of a major lung cancer research association.

The online survey was conducted by the International Association for the Study of Lung Cancer (IASLC), with more than 1,500 respondents.

More than 90% of physicians in the survey said tobacco cessation should be part of routine care for lung cancer patients who use tobacco.

Respondents cited an expectation of resistance from patients and uncertainty about how to help patients to quit smoking as reasons for not routinely offering such assistance.

"Clearly there is a need to increase tobacco cessation assistance for cancer patients," says Carolyn Dresler, MD, member of the IASLC board of directors and its committee on tobacco cessation, in a statement. "This study really helps us better understand the barriers to implementing tobacco cessation and gives us a target to improve cessation support."

Cancer patients won't get any help soon from a new drug to treat chemotherapy-induced nausea and vomiting, as the FDA declined to approve it.

A.P. Pharma said it had received a complete response letter on its drug APF530, an extended-release version of the 5-HT3 serotonin antagonist granisetron. According to the firm, a single subcutaneous injection maintains therapeutic levels for up to 5 days.

The company said that the FDA was requesting a new "human factors validation study" to test the syringe system to be used with the agent (a previous two-syringe system had been rejected by the FDA in 2010.) The agency also wanted new analyses of existing phase III data to clarify responses in patients receiving moderately versus highly emetogenic chemotherapies.

In addition, the FDA had issues with quality control at the company's manufacturing facility, the firm said.

A.P. Pharma said the FDA's concerns "are addressable" and it projected APF530 approval and launch by mid-2014.

Another Compounding Pharmacy Recall

Yet another compounding pharmacy in Massachusetts was found wanting by inspectors from the FDA and the state's pharmacy board, leading to a complete recall of all products dispensed since Jan. 1, 2013.

The inspections at Pallimed Pharmacy in Woburn, Mass., found visible, filamentous particulates in vials of a wide range of supposedly sterile compounded products, according to an FDA recall notice.

It said the particulates had not been identified and therefore the specific risks were uncertain. "However, particulate matter has the potential to damage or obstruct blood vessels, which could induce emboli, cause systemic allergic reaction, or cause tissue responses to the foreign material," it added.

The recalled products included medications for erectile dysfunction, testosterone replacement, vitamin insufficiency, and eye conditions, the FDA said. They had been shipped to more than 20 states across the country.

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